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The Position

Are you passionate about making a significant impact in the pharmaceutical industry? Do you thrive in a dynamic, collaborative environment? If so, Boehringer Ingelheim invites you to join us as a Global Senior Submission Manager in our Regulatory Affairs department.

In this pivotal role, you will have the opportunity to provide strategic input to the Regulatory Subteam, lead and coordinate global and technical compilation, and manage worldwide submission of dossiers for new chemical and biological marketing authorization applications. Your expertise in process development, eSubmission-specific requirements, and regulatory strategies will be invaluable as you navigate unique situations and challenges.

Join us and contribute to our commitment to improving human and animal health. At Boehringer Ingelheim, we value the unique skills and perspectives of our team members and believe that our diverse workforce is our greatest strength.

Tasks & responsibilities

As a Senior Global Submission Manager, you will oversee submission planning and preparation activities, ensuring the integrity of our databases and providing guidance to the Global Submission Manager. Your strategic input will be crucial to the Head Global Submission Management and to the overall success of our mission. Additionally, your key responsibilities will include:

• Leading submission planning discussions, ensuring alignment on roles, responsibilities, and upcoming deliverables.

• Understanding detailed global electronic regulatory requirements.

• Managing and executing planning, compilation, and dispatch of submissions to Health Authorities during the application lifecycle and global Marketing Authorisation Applications (MAA).

• Creating and updating entries in the Regulatory Information Management system (Veeva Vault RIM).

• Liaising with Regulatory subteam/RET to provide required submission-relevant documents on time and in submission-ready format.

• Participating in discussions/meetings to develop and communicate submission strategies for applications.

• Monitoring compliance with submission standards and submission process (internal & external).

• Overseeing Regulatory technology and process development activities as needed.

• Developing training materials and leading efforts to implement training related to regulatory submission activities.

• Standardizing best practices for management of regulatory submissions to ensure consistency.

• Ensuring processes related to eCTD readiness submission documentation are adhered to.

• Acting as a liaison between Global Regulatory Strategic Lead (GRSL)/Regional Project Manager (RPM) and key cross-functional partners for major submission - Global tracking list.

• Overseeing the work of the Global Submission Manager and assisting MAAs.

• Leading a Submission Capability and/or a small/mid-size standalone project.

• Independently managing the planning, coordination, and timely submission of original marketing authorization applications, high quality electronic dossiers, complex lifecycle dossiers, and related responses to health authorities.

Requirements

The ideal candidate for the Global Senior Submission Manager position should have:

• Bachelor´s degree in scientific or technical discipline with extensive years of experiences in the pharmaceutical industry, Master´s degree would be beneficial

• Expert knowledge of the regulatory environment

• Experience in leading projects or services in a global matrix environment

• Experience in leading peers or lower levels on submission processes, and submission creation and delivery

• Expertise in maintaining timelines and pushing peers and key stakeholders to deliver according to schedule

• Expert knowledge of general Regulatory Affairs processes across groups, especially those centered on submission creation and timelines, key stakeholders, and delivery

• Showcase your proven expertise in process design/management, process consulting, organizational change management, and project management. Experience in various local and global roles is a plus.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process:

Step 1: Online application - application deadline is 13th of June, 2024.

Step 2: Virtual meeting in the period from end of June, 2024

Step 3: On-site interviews beginning of July, 2024

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.